NCT00803114

Epidural Morphine Following Vaginal Delivery

Epidural Morphine Following Vaginal Delivery: A Randomised, Double-Blind, Placebo-Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Mount Sinai Hospital, Canada · Academic / Other
• Sex: Female
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The investigators believe that pain management following a vaginal delivery can be improved. Many women receive epidural medication during labor and delivery, and the investigators felt that using the epidural following delivery might improve the first day pain. This study is to determine whether a single dose of epidural morphine given to mothers after a vaginal delivery will reduce the perineal pain in the postpartum period.

Detailed description

Vaginal deliveries comprise 80-85% of all deliveries. Although this is felt to be natural and safe, this route can be associated with significant perineal trauma and subsequent postpartum perineal pain. The degree of perineal trauma varies from the minimum of vaginal stretching and distension associated with labor, to episiotomy and significant perineal tears. In spite of the differences in the degree of injury following vaginal delivery, postpartum pain therapy is poorly organized and at best consists of simple analgesics and anti-inflammatory drugs. The purpose of this study is to determine if a single dose of epidural-administered morphine offers additional advantage to an organized program for the management of immediate postpartum perineal pain following vaginal delivery.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Preservative-free epidural morphine	One time dose of preservative-free epidural morphine 2.5 mg given within one hour following vaginal delivery
DRUG	Placebo	5 ml of epidural preservative-free saline given within one hour following vaginal delivery

Timeline

• Start date: 2002-03-01
• Primary completion: 2004-11-01
• Completion: 2005-02-01
• First posted: 2008-12-05
• Last updated: 2009-01-14
• Results posted: 2008-12-05

Locations

1 site across 1 country: Canada